2254. Misbranding of sulfathiazole tablets.   U. S. v. Jordan James Sullivan (Sulli
van's Pharmacy). Tried to the court. Judgment for the Government.
Defendant fined $200 and placed on two years' probation. Appealed to
the Circuit Court of Appeals; judgment of District Court reversed. Cer-
tiorari to Supreme Court} judgment of District Court affirmed. (F. D. C.
No. 16600.   Sample Nos. 64091-F, 64236-F.)
INFORMATION FILED : January 2,1946, Middle District of Georgia, against Jordan
James Sullivan, trading as Sullivan's Pharmacy, at Columbus, Ga.
?See also Nos. 2251, 2255.
March 15,1944, from the State of Illinois into the State of Georgia.
LABEL, IN PART :   (When shipped) "1000 Tablets (Bisected) SULF ATHIAZOLE
. (2-sulfanilamidothiazole) 0.5 gm. (7.7 grs.) Abbott-List No. 3430 Caution-
To be used only by or on the prescription of a physician * * * Abbott
Laboratories   North Chicago, 111., U. S. A."
ALLEGED VIOLATION : On or about September 29 and December 13,1944, while the
drug was being held for sale after shipment in interstate commerce, the defend-
ant caused a number of tablets to be removed from the bottles in which they
had been shipped in interstate commerce and caused them to be repacked in
boxes bearing no other label than the statement "Sulfothiazal" or "Sulfathia-
zole," which acts caused the article to be misbranded.
NATURE OF CHARGE: Misbranding, Section 502 (f) (1), the labeling on the box
failed to bear adequate directions for use; and, Section 502 (f) (2), it failed
to bear such adequate warnings against use in those pathological conditions
where the use of the article may be dangerous to health, and against unsafe
dosage and methods and duration of administration, in such manner and form,
as are necessary for the protection of users.
DISPOSITION : On September 2, 1946, the case was tried to the court and the
defendant was convicted. The sentence of the court was that the defendant pay
a fine of $200, and that he be placed on probation for 2 years. On May 12,1947,
the case having been appealed to the Circuit Court of Appeals for the Fifth
Circuit, the judgment of the District Court was reversed. The Government
petitioned the Supreme Court for a writ of certiorari, which was granted; and
on January 19,1948, the following opinion was delivered by the Supreme Court,
reversing the Circuit Court of Appeals and sustaining the judgment of the
District Court, with Justices Frankfurter, Reed, and Jackson dissenting:
JUSTICE BLACK: "Respondent, a retail druggist in Columbus, Georgia, was
charged in two counts of an information with a violation of ? 301 (k) of the
Federal Food, Drug, and Cosmetics Act of 1938. That section prohibits 'the
doing of any ... act with respect to, a . . . drug . . .if such act is done
while such article is held for sale after shipment in interstate commerce and
results in such article being misbranded.'x Section 502 (f) of the Act declares
a drug 'to be misbranded . . . unless its labeling bears (1) adequate directions
for use; and (2) such adequate warnings against use . . . dangerous to health,
or against unsafe dosage ... as are necessary for the protection of users.'
The information charged specifically that the respondent had performed certain
acts which resulted in sulfathiazole being 'misbranded' while 'held for sale
after shipment in interstate commerce.'
"The facts alleged were these: A laboratory had shipped in interstate com-
merce from Chicago, Illinois, to a consignee at Atlanta, Georgia, a number of
bottles, each containing 1,000 sulf athiazole tablets. These bottles had labels
affixed to them, which, as required by ? 502 (f) (1) and (2) of the Act, set out
adequate directions for the use of the tablets and adequate warnings to protect
ultimate consumers from dangers incident to this use.2 Respondent bought one
of these properly labeled bottles of sulf athiazole tablets from the Atlanta
1 "Sec. 301. The following acts and the causing thereof are hereby prohibited:
"(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or
any part of the labeling of, or the doing of any other act with respect to, a food, drug,
device, or cosmetic, if such act is done while such article is held for sale after shipment
in interstate commerce and results in such article being misbranded." 52 Stat. 1042,
21 U. S. C. ? 331 (k).
1 The following inscription appeared on the bottle labels as a compliance with ? 502
(f) (1) which requires directions as to use: "Caution.-To be used only by or on the
prescription of a physician." This would appear to constitute adequate directions since
it is required by regulation issued by the Administrator pursuant to authority of the
Act. 21 C. F. R. Cum. Supp. ? 2.106 (b) (3). The following appeared on the label of
the bottles as a compliance with ?502 (f) (2) which requires warnings of danger:
"Warning.-In some individuals Sulfathiazole may cause severe toxic reactions. Daily
blood counts for evidence of anemia or leukopenia and urine examinations for hema-
turia are recommended.
"Physicians should familiarize themselves with the use of this product before it is
administered. A circular giving full directions and contraindications will be furnished
upon request."
the tablets for resale. On two separate occasions twelve tablets were removed
from the properly labeled and branded bottle, placed in pill boxes, and sold to
customers". These boxes were labeled 'sulfathiazole.' They did not contain
the statutorily required adequate directions for use or warnings of danger.
"Respondent's motion to dismiss the information was overruled, a jury was
waived, evidence was heard, and respondent was convicted under both counts.
"The Circuit Court of Appeals reversed. 161 F. 2d 629. The court thought
that as a result of respondent's action the sulfathiazole became 'misbranded'
within the meaning of the Federal Act, and that in its 'broadest possible sense'
the Act's language 'may include what happened.' However, it was also of the
opinion that the Act ought not to be taken so broadly but held to apply only to
the holding for the first sale by the importer after interstate shipment.' Thus
the Circuit Court of Appeals interpreted the statutory language of ? 301 (k)
'while such article is held for sale after shipment in interstate commerce' as
though Congress had said 'while such article is held for sale by a person who
had himself received it by way of a shipment in interstate commerce.' We
granted certiorari to review this important question concerning the Act's
coverage.
"First. The narrow construction given ? 301 (k) rested not so much upon
its language as upon the Circuit Court's view of the consequences that might
result from the broader interpretation urged by the Government. The court
pointed out that the retail sales here involved were made in Columbus nine
months after this sulfathiazole had been shipped from Chicago to Atlanta. It
was impressed by the fact that, if the statutory language 'while such article is
held for sale after shipment in interstate commerce' should be given its literal
meaning, the criminal provisions relied on would 'apply to all intrastate sales
of imported drugs after any number of intermediate sales within the State and
after any lapse of time; and not only to such sales of drugs, but also to similar
retail sales of food, devices and cosmetics, for all these are equally covered by
these provisions of the Act.' The court emphasized that such consequences
would result in far-reaching inroads upon customary control by local authori-
ties of traditionally local activities, and that a purpose to afford local retail
purchasers federal protection from harmful foods, drugs and cosmetics should
not be ascribed to Congress in the absence of an exceptionally clear mandate,
citing Federal Trade Commission v. Bunte Bros., 312 U. S. 349. Another
reason of the court for refraining from construing the Act as applicable to
articles misbranded while held for retail sale, even though the articles had
previously been shipped in interstate commerce, was its opinion that such a
construction would raise grave doubts as to the Act's constitutionality. In
support of this position the court cited Labor Board v. Jones & Lauffhlin Steel
Corp., 301 TJ. S. 1, 30, and Schechter Poultry Corp. v. United States, 295
U. S. 495.
"A restrictive interpretation should not be given a statute merely because
Congress has chosen to depart from custom or because giving effect to the
express language employed by Congress might require a court to face a consti-
tutional question. And none of the foregoing cases, nor any other on which
they relied, authorizes a court in interpreting a statute to depart from its
clear meaning. When it is reasonably plain that Congress, meant its Act
to prohibit certain conduct, no one of the above references justifies.a dis-
tortion of the congressional purpose, not even if the clearly correct purpose
makes marked deviations from custom or leads inevitably to a holding of
constitutional invalidity. Although criminal statutes must be so precise and
unambiguous that the ordinary person can know how to avoid unlawful
conduct, see Krauss & Bros., Inc. v. United States, 327 TJ. S. 614, 621-622, even
in determining whether such statutes meet that test, they should be given
their fair meaning in accord with the evident intent of Congress. United
States v. Raynor, 302 U. S. 540, 552.
"Second. Another consideration that moved the Circuit Court of Appeals
to give the statute a narrow construction was its belief that the holding in
*this case with reference to misbranding of drugs by a retail druggist would
necessarily apply also to 'similar retail sales of food, devices and cosmetics,
for all of these,' the court said, 'are equally covered by the same provisions
of the Act.' And in this Court the effect of such a possible coverage of the
Act is graphically magnified.   We are told that its application to these local
parlor operators to reproduce the bulk container labels on each individual
item when it is taken from the container to sell to a purchaser.- It is even
prophesied that, if ?301 (k) is given the interpretation urged by the Gov-
ernment, it will later be applied so as to require retail merchants to label
sticks of candy and sardines when removed from their containers for sale.
"The scope of the offense which Congress defined is not to be judicially nar-
rowed as applied to drugs by envisioning extreme possible applications of
its different misbranding provisions which relate to food, cosmetics, and the
like. There will be opportunity enough to consider such contingencies should
they ever arise. It may now be noted, however, that the Administrator of the
Act is given rather broad discretion-broad enough undoubtedly to enable
him to perform his duties fairly without wasting his efforts on what may
be no more than technical infractions of law. As an illustration of the Ad-
ministrator's discretion, ? 306 permits him to excuse minor violations with
a warning if he believes that the public interest Will thereby be adequately
served. And the Administrator is given extensive authority under ?? 405,
503 and 603 to issue regulations exempting from the labeling requirements
many articles that otherwise would fall within this portion of the Act. The
provisions of ? 405 with regard to food apparently are broad enough to per-
mit the relaxation of some of the labeling requirements which might otherwise
impose a burden on retailers out of proportion to their value to the consumer.
"Third. When we seek the meaning of ?301 (k) from its language we
find that the offense it creates and which is here charged requires the doing
of some act with respect to a drug (1) which results in its being misbranded,
(2) while the article is held for sale 'after shipment in interstate commerce.'
Respondent has not seriously contended that the 'misbranded' portion of
?301 (k) is ambiguous. Section 502 (f), as has been seen, provides that a
drug is misbranded unless the labeling contains adquate directions and ade-
quate warnings. The labeling here did not contain the information which
? 502 (f) requires. There is a suggestion here that, although alteration,
mutilation, destruction, or obliteration of the bottle label would have been a
'misbranding,' transferring the pills to non-branded boxes would not have
been, so long as the labeling on the empty bottle was not disturbed. Such an
argument cannot be sustained. For the chief purpose of forbidding the de-
struction of the label is to keep it intact for the information and protection
of the consumer. That purpose would be frustrated when the pills the con-
sumer buys are not labeled as required, whether the label has been torn from
the original container or the pills have been transferred from it to a non-labeled
one.   We find no ambiguity in the misbranding language of the Act.
"Furthermore, it would require great ingenuity to discover ambiguity in
the additional requirement of ? 301 (k) that the misbranding occur 'while such
article is held for sale after shipment in interstate commerce.' The words
accurately describe respondent's conduct here. He held the drugs for sale
after they had been shipped in interstate commerce from Chicago to Atlanta.
It is true that respondent bought them nine months after the interstate
shipment had been completed by their delivery to another consignee. But the
language used by Congress broadly and unqualifiedly prohibits misbranding
articles held for sale after shipment in interstate commerce, without regard
to how long after the shipment the misbranding occurred, how many intra-
state sales had intervened, or who had received the articles at the end of
the interstate shipment. Accordingly we find that the conduct of the re-
spondent falls within the literal language of ? 301 (k).
"Fourth. Given the meaning that we have found the literal language of
? 301 (k) to have, it is thoroughly consistent with the general aims and
purposes of the Act. For the Act as a whole was designed primarily to
protect consumers from dangerous products. This Court so recognized in
United States v. Dotterweich, 320 U. S. 277, 282, after reviewing the House
and Senate Committee Reports on the bill that became law. Its purpose was
to safeguard the consumer by applying the Act to articles from the moment
of their introduction into interstate commerce all the way to the moment
of their delivery to the ultimate consumer. Section 301 (a) forbids the
'introduction or delivery for introduction into interstate commerce' of mis-
branded or adulterated drugs; ? 301 (b) forbids the misbranding or adultera-
tion of drugs while 'in interstate commerce'; and ?301 -(c)  prohibits the
delivery or proferred delivery thereof for pay or otherwise.' But these three
paragraphs alone would not supply protection all the way to the consumer.
The words of paragraph (k) 'while such article is held for sale.after shipment
in interstate commerce' apparently were designed to fill this gap and to
extend the Act's coverage to every article that had gone through interstate
commerce until it finally reached the ultimate consumer. Doubtless it was
this purpose to insure federal protection until the very moment the articles
passed into the hands of the consumer by way of an intrastate transaction that
moved the House Committee on Interstate and Foreign Commerce to report
on this section of the Act as follows: 'In order to extend the protection of
consumers contemplated by the law to the full extent constitutionally possible,
paragraph (k) has been inserted prohibiting the changing of labels so as to
misbrand articles held for sale after interstate shipment.'* We hold that
g301 (k) prohibits the misbranding charged in the information.
"Fifth. It is contended that the Act as we have construed it is beyond any
authority granted Congress by the Constitution and that it invades the power
of the States. A similar challenge was made against the Pure Food and Drug
Act of 1906, 34 Stat. 768, and rejected, in McDermott v. Wisconsin, 228 U. S.